Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)
This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine.
The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elicit ELISA IgG titers greater than or equal to 1:500 and TNA anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine recipients.
Focus: Ricin Vaccine for Safety and Immuogenicity Outcome
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Phase 1 Escalating, Multiple-Dose Study to Evaluate the Safety and Immunogenicity of Recombinant Ricin Toxin A-Chain 1-33/44-198 (rRTA 1-33/44-198) Vaccine (RVEc™) in Healthy Adults|
- The nature, severity, relationship to vaccine, treatment or intervention offered if any, resolution or outcome, and frequency of adverse events (AE) for the assessment population (all subjects receiving one or more vaccinations under this protocol). [ Time Frame: Subjects will be followed for safety for 7 months after the last dose of the vaccine; SAEs for duration for study ] [ Designated as safety issue: Yes ]Endpoint measurements will be evaluated on a per dose basis and overall. Percentage of vaccinated subjects 1)without symptoms, 2)with any category of local reaction (grade 1-4), 3)with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4), 4)with generalized allergic reactions, 5)with each AE will be reported.
- Total anti-ricin IgG antibody titers as determined by the enzyme-linked immunosorbent assay (ELISA) and anti-ricin toxin-neutralizing antibody titers as determined by the colorimetric toxin neutralization assay (TNA) at all specified time points. [ Time Frame: Time points include: 7, 14, and 28 days after each vaccination, 6 months, the 9-month close-out evaluation, and 12 months ] [ Designated as safety issue: No ]Endpoint measurements will be evaluated for subjects in the per protocol population (subjects compliant with vaccination and titer schedules, including those subjects who received three doses of the vaccine and had at least one titer result after dose 3 and then withdrew from the study).
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Experimental: Group 1||
20ug/dose x 3 doses
Other Name: 20ug dose
|Experimental: Group 2||
50ug/dose x 3 doses
Other Name: 50ug dose
|Experimental: Group 3||
100ug/dose x 3 doses
Other Name: 100ug dose
|United States, Maryland|
|Clinical Research Department, U.S. Army Medical Research Institute of Infectious Diseases|
|Fort Detrick, Maryland, United States, 21702|
|Principal Investigator:||Ronald Reisler, MD||U.S. Army Medical Research Institute of Infectious Diseases|